BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3935864 · Received July 15, 2014

    Report

    Report Number
    3007566237-2014-01967
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0497-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8835, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014, THE PUMP STALLED DUE TO A MOTOR STALL AT 10:42; MOTOR STALL RECOVERY OCCURRED AT 10:48. ON (B)(6) 2014 AT 06:46, A ROLLER STUDY WAS PERFORMED. ON (B)(6) 2014, THE PUMP STALLED AT 02:27 AND NEVER RECOVERED; ON (B)(6) 2014 AT 02:27 A STOPPED PUMP PERIOD MAY EXCEED TUBE SET MESSAGE WAS RECORDED. THE PUMP WAS ALARMING. THE PATIENT WAS GOING THROUGH WITHDRAWAL; IT WAS UNKNOWN EXACTLY WHEN IT BEGAN. THE PATIENT SYMPTOMS WERE NERVOUS, ANXIOUS, SHAKING, AND SWEATING. THE PATIENT WAS GIVEN FENTANYL VIA IV (INTRAVENOUS). THE PUMP WAS REPLACED. THE DEVICE SYSTEM WAS DELIVERING MORPHINE AND CLONIDINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER REPORTED THE PATIENT WAS IN PAIN AND REPORTING NAUSEA. THERE WAS MORE THAN ONE MOTOR STALL NOTED IN THE EVENT LOGS DURATION UNKNOWN. THE CAUSE OF THE WITHDRAWAL WAS PUMP MOTOR STALL. THE PATIENT WAS DOING WELL AND RECEIVING EFFECTIVE THERAPY. THE NEW PUMP WAS DELIVERING GOOD THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413753 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention